Therapeutic Study of ONO-4819CD for Ulcerative Colitis

This study has been terminated.
(terminated)
Sponsor:
Collaborator:
National Institute of Biomedical Innovation
Information provided by:
Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT00296556
First received: February 24, 2006
Last updated: April 27, 2009
Last verified: April 2009
  Purpose

The purpose of this study is to investigate whether ONO-4819CD is safe and effective in the treatment of mild to moderate ulcerative colitis.


Condition Intervention Phase
Ulcerative Colitis
Drug: Rivenprost (drug)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Trial of ONO-4819CD for Treatment of Mild to Moderate Ulcerative Colitis.

Resource links provided by NLM:


Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • Remission evaluated by DAI scores at 14 and 28 days

Secondary Outcome Measures:
  • Improvement by DAI scores; Change in DAI scores; CAI scores at 3, 7, 14 and 28 days; Colonoscopic and histopathological scores at 14 and 28 days; Clinical severity and symptom scores at 7, 14 and 28 days; Cytokines at 7, 14 and 28 days; Adverse effects.

Enrollment: 7
Study Start Date: February 2006
Study Completion Date: March 2008
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Ulcerative colitis is a relapsing disease of unknown cause characterized by bloody diarrhea. Therapy usually involves 5-aminosalicylates, corticosteroids and immunosuppressants. However, steroid resistance and dependency can become problematic. Immunosuppressive drugs, such as azathioprine, are beneficial but may have serious side effects. Therefore, new therapeutic approach is needed.

Prostaglandin E2 is one of the prostanoids, which is involved with innate immunity. PGE2 induces oral tolerance to specific antigen in the small intestine and downregulates the production and release of proinflammatory cytokines by macrophages and neutrophils. Accordingly, PGE2 is considered to be the mediator of mucosal protection.

Recently, it was elucidated that disruption of EP4 gene, which is one of PGE receptors, caused severe colitis in mice. Moreover, EP4-selective agonist (AE1-734) was also revealed to ameliorate severe dextran sodium sulfate-induced colitis in mice. We therefore examined the effects of 2 weeks intravenous EP4-selective agonist therapy for patients with mild to moderate ulcerative colitis.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of ulcerative colitis
  2. Mild to moderate ulcerative colitis refractory to 5-aminosalicylates therapy.
  3. 20 years and above
  4. Must obtain written informed consent

Exclusion Criteria:

  1. Corticosteroids therapy within two weeks before enrollment
  2. Immunosuppressive therapy within three months before enrollment
  3. Leukocytapheresis therapy within one month before enrollment
  4. Blood transfusion within two weeks before enrollment
  5. Impaired renal function
  6. Impaired hepatic function
  7. Uncontrolled hypertension/hypotension
  8. Uncontrolled arrhythmia
  9. Impaired cardiac function
  10. Cancer
  11. Uncontrolled diabetes
  12. Interstitial pneumonia
  13. Glaucoma
  14. History of colon resection
  15. Infectious diseases needing medical treatments
  16. Drug allergy
  17. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296556

Locations
Japan
Kyoto University, Graduate School of Medicine
Kyoto, Japan, 606-8501
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
National Institute of Biomedical Innovation
Investigators
Study Chair: Shuh Narumiya, MD, PhD Kyoto University, Graduate School of Medicine
Principal Investigator: Tsutomu Chiba, MD, PhD Kyoto University, Graduate School of Medicine
  More Information

Publications:
Responsible Party: Hiroshi Nakase / Associate Professor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT00296556     History of Changes
Other Study ID Numbers: TRC05PG-II-1
Study First Received: February 24, 2006
Last Updated: April 27, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyoto University, Graduate School of Medicine:
Ulcerative colitis
EP4 agonist
PGE2

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014